contamination control testing and certification plan for laminar flow clean rooms, laminar flow work

Contamination Control Testing and Certification PlanforLaminar Flow Clean Rooms, Laminar Flow Work Stationsand Controlled EnvironmentsDocument Number-D-17874Prepared by: Signature on file Approved: Signature on fileWilliam C. Neiderheiser Andre Yavrouian- Supervisor Contamination Control Laboratory Flight hardware MaterialsAnalysis GroupApproved: Signature on fileTimothy P. O’DonnellSection Manager 353Thermal & Propulsion EngineeringJuly 08, 1999TABLE OF CONTENTS1.0- Scope and Purpose (2)2.0- Applicable documents (2)3.0- D efinitions (3)3.1- G eneral (3)3.2- D escriptors (4)3.3- O ccupancy states (4)4.0-Acronyms/ Symbols (4)5.0-Certification Requirements for Clean rooms and Associated Environments at JPLand Related JPL off site facilities (5)5.1-General (5)5.2-Required testing (5)5.3-Optional testing (5)6.0-Outside Contractor Cleanroom Certifications and Requirements (6)6.1-New Cleanroom Construction (6)7.0-HEPA/ULPA and Related filter replacements (6)7.1-Pre-filter replacements (6)8.0-Certification class levels (Cleanliness comparison ISO 14644-1 and FED STD 209E) (7)Table 1 (7)8.1-Classification of Cleanroom or Controlled environments (7)8.2-Re-Certification Requirements (7)9.0- Certification label (8)Figure 1- sample of certification label (8)10.0 -Non-Compliance (9)Figure 2- Sample of Non-Compliance Label (9)11.0 -Record keeping (9)12.0- Reporting to the Customer (10)13.0-How to obtain Certification services (10)Figure3- Basic Clean room rules (11)11.0-SCOPE AND PURPOSEThe scope of this document is limited to periodic testing and certification of laminar flow clean rooms and other controlled environments. Tests and certifications performed are specified by project contamination control plans prepared as part of the project Mission Assurance Program which resides in the DMIE Project Leadership Process (PCP). Refer to the Contamination Control subpolicy (DesignBuild, Assemble and Test Process, Section 2.2.3) for DBAT Process Contamination Control Plan requirements.Interim monitoring is performed by Clean room Technicians (Section 3130). In certain circumstances, the Contamination Control Laboratory will be funded to perform continuous monitoring as required by the Project requirementsThe purpose of this document is to define the JPL Contamination Control clean room, clean bench and controlled environment testing and certification plan in accordance with ISO/DIS 14644-2:1998 (E) to implement ISO 14644-1 based on risk assessment. The risk assessment to a particular clean room application will affect the Testing and Certification plan, the interpretation of the Testing data, the actions that will be taken as a result of the Testing data collected, the selection of parameters to be measured from ISO/DIS 14644-2:1998 (E) Table 2 and the selection of parameters to be measured in ISO/DIS 14644-2:1998 (E) Table A.1. This plan is based on ISO/DIS 14644-2:1998 (E) section 4.3 Monitoring and will include individual written reports for all laminar flow Clean Rooms, Controlled Environments and Laminar Flow Clean Benches at JPL per ISO/DIS 14644-2:1998 (E) , section 4.3.2, and will include Note 1 and Note 2 under this Certification program.2.0- APPLICABLE DOCUMENTSNote: The following documents are used to govern clean room testing for various individual cleanliness plans and applications and become part of certification and testing practices as required by the project or customer.ISO 14644-1- Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness ISO/DIS 14644-2:1998 (E)- Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1American Society for Testing and Materials (ASTM) Standards:F25 Method for Sizing and Counting Airborne Particulate Contamination in Cleanroomsand other Dust-controlled areas Designed for Electronic and Similar applicationsF50 Method of Test for Continuous Counting and Sizing of Airborne particles in DustControlled areas by the Light -Scattering Principle.22.0- APPLICABLE DOCUMENTS (Cont.)D-17874 NASA:SN-C-0005 Rev. D Specification; Contamination Control Requirements for the Space Shuttle ProgramGSFC-TLS-PR-7324-01: Contamination Control Procedure for the Tapelift Sampling ofSurfacesMilitary Standard:MIL-STD- 1246C: Product Cleanliness Levels and Contamination Control program3.0 - DEFINITIONS3.1 - GeneralClean Room- A room in which the concentration of particles is controlled and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room, and in which other relevant parameters i.e., temperature, humidity and pressure are controlled as necessary.Clean Zone, Controlled Environment, Clean Bench- A space dedicated within a room where the concentration of airborne particles is controlled and has the same parameters as a cleanroom. This zone may be in an open or enclosed area and may or may not be located in a clean room.Installation- A Clean Room or one or more Clean Zones, together with all appurtenant structures, air treatment systems, services and utilities.Classification- The level (or the process of specifying or determining the level) of airborne particulate cleanliness applicable to a Clean Room or Clean Zone, expressed in terms of ISO class N, which represents the maximum allowable concentrations (in particles per cubic meter of air) for considered sizes of particles. Particle size- A diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent to the response produced by the particle being measured.Particle concentration- The number of individual particles per unit volume of airParticle size distribution- Cumulative distribution of particle concentration as a function of particle size.Ultra fine particle- A particle with an equivalent diameter less than 0.1µ.Macroparticle- A particle with an equivalent diameter greater than 5.0µ.Fiber- A particle having an aspect (Length to width) ratio of 10 or moreCustomer- The organization or person responsible for requesting the services of the Contamination Control Laboratory Services.Supplier- The organization engaged to satisfy the specified requirements of the Clean Room or Clean Zone, including the Contamination Control Lab.33.2-DESCRIPTORSU descriptor- A measured or specified concentration, in particles per cubic meter of air, including ultrafine particles.M descriptor- A measured or specified concentration of macroparticles per cubic meter of air, expressed in terms of the equivalent diameter that is characteristic of the measurement method used.3.3-OCCUPANCY STATESAs built is a condition where the installation is complete with all services connected and functioning but with no production equipment, materials or personnel present.At rest is the condition of the installation with the equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present.Operational is the condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon.4.0 - ACRONYMS/ SYMBOLSDPC- Discreet Particle Counter, An instrument, such as an optical particle counter or a condensation nucleus counter, capable of resolving responses from individual particles.CNC- Condensation Nucleus Counter, An instrument for counting small airborne particles, approximately 0.01µ and larger, by optically detecting droplets formed by condensation of vapor upon the particles. Sometimes known as an aerosol photometer.µ- Micron (Micrometer), A unit of measurement equal to one-millionth of a meter or approximately0.00003937 inch.ISO- International Organization for StandardizationN-NumberHEPA- High Efficiency Particulate Air filtersULPA- Ultra Low Penetration Air filterDOP- Dioctylphthalate, A liquid pump oil type fluid which is aerosolized and used to challenge HEPA and ULPA filters for efficiency.JPL- Jet Propulsion Laboratory45.0- C ERTIFICATION REQUIREMENTS FOR CLEAN ROOMS AND ASSOCIATEDENVIRONMENTS AT JPL AND RELATED JPL OFF SITE FACILITIES5.1- GeneralThe Contamination Control Laboratory personnel will perform Laminar Flow Cleanroom, Clean Bench and Controlled Environment Certification for the JPL community per the ISO/DIS 14644-2:1998 (E) Standard. The classification of the Clean Areas will be documented per the ISO 14644-1 standard. These tests include but are not limited to Airborne particulate counting and sizing, Air velocity testing, and differential pressure testing. All HEPA and ULPA filtered areas will be tested under these conditions to prove compliance with the standard. The Controlled Environment areas (> class 100,000) will require only particulate testing unless otherwise requested by the customer. The optional tests in Annex A Table A.1 of ISO/DIS 14644-2:1998 (E) will not be performed unless specifically requested by the customer or determined to be necessary by Contamination Control personnel.5.2- Required testingContamination Control personnel will measure the square footage of each Clean Room or Controlled Environment to establish the number of samples to be taken in the area. The Contamination Control personnel will take the proper number of samples at each location as defined by the ISO 14644-1 Annex B Section B.4.1.1 using a (DPC) Calibrated particle counter (Calibrated within 180 days) designated to count the required particle sizes for the area which will determine the classification of the clean area.5.2.1- Contamination Control personnel will perform a velocity test in the clean area, and the number of tests performed will be based on the square footage of the area. This information will be recorded on the Certification data or memo to the customer. Contamination Control personnel will determine if theflow is adequate for the specified area and make recommendations to the customer in writing where theflow is deemed to be low or out of specification.5.2.2-Differential pressure readings will be performed in all clean areas to determine the existence of positive pressure. Where there are rooms that already have differential pressure gauges, the readings on those gauges will be recorded on the data for the customer providing that the gauge is calibrated. If the gauge is out of calibration, Contamination control personnel will perform the test and record the information on the data sheet or memo provided to the customer.5.2.3-The Contamination Control personnel will perform a visual cleanliness survey of the Clean Area tobe tested under the ISO standard. This test will be conducted per the SN-C-0005 Contamination Control Requirements for the Space Shuttle (Section 1.4) for visual cleanliness. Survey data will be recorded and kept on file.5.3- OPTIONAL TESTING5.3.1-The Contamination Control Lab can also provide particulate fallout plates to determine the largersize particulates which may be entering the clean area.5.3.2-Tapelift samples can be provided for testing hardware cleanliness, cleanliness of the walls, floors orany equipment in the clean area.5.3.3-The Contamination Control Laboratory will also perform Low-Volatile Residue sampling by providing a clean sample plate (For airborne collection) or (wipe samples) for product testing if required by the customer56.0- OUTSIDE CONTRACTOR CLEANROOM CERTIFICATIONS AND REQUIREMENTS Contractors who perform work on JPL clean rooms shall comply with all the applicable requirementsset forth in the ISO 14644-1 and ISO/DIS 14644-2:1998 (E) controlling documents. The Customer shall instruct the Contractor to interface with Contamination Control Service personnel on all Certification and Clean Room installations at JPL. The contractor shall supply to the JPL Contamination Control Laboratory a documentation package that certifies the work complies with all the ISO standard requirements, and specifies the type of work performed, and any optional tests performed.6.1- New Cleanroom constructionThe contractor shall build the new Clean Room facility in accordance to the ISO 14644 documentsand supply to the JPL Contamination Control Laboratory documentation which shall includeall tests in accordance with that document, and the sizes, part number or manufacturer number,and statement that the filters were not tested with Dioctylphthalate (DOP) , plasticizer test materialsor other non- approved JPL test methods with a CNC for the HEPA or ULPA filter installation. Low outgassing materials shall be considered in the construction phase. In addition the clean room must meet the requirements of MIL-STD 1246C Level A in Table II Non-Volatile Residue Cleanliness Levels. Waivers to this must be approved by management and documentation must be supplied to theJPL Contamination Control Laboratory for their files.7.0-HEPA/ULPA AND RELATED FILTER REPLACEMENTSThe HEPA/ULPA filters have a life expectancy of 3-5 years in accordance with the manufacturers recommendations. Typically the filters at JPL require replacement in 6-7 years. There are some filters that have been purchased by JPL that have a life expectancy of 10 years, warranted by the manufacturer, at additional costs. The Contamination Control personnel will determine by the tests performed in the certification process when the filters require replacement based on the air flow or the differential pressure drop of the filter. The customer will be notified of this condition and a recommendation for replacement will be sent to the customer. This replacement can be performed by the Contamination Control Lab in most cases.7.1-Pre-Filter replacementPre-filters will extend the life of the HEPA and ULPA filters. The Contamination Control Lab will replace these accessible filters at the time of Certification of the Clean Room, Controlled Environment, Clean Zone or Clean Bench. Pre-filters should be checked monthly by the customer or the Contamination Control lab personnel to determine the loading of the filter. The Contamination Control Lab will maintain a stockroom with most pre-filter sizes available. Special sizes of filters require placing an order.68.0- CERTIFICATION CLASS LEVELSClean Room, Controlled Environment or Clean Bench shall have a designated class level numberN which corresponds to the ISO 14644-1 Table 1 cleanliness classes. Listed below are the cleanliness classes and a comparison to the FED-STD 209E document.TABLE 1-Cleanliness comparison of ISO 14644-1 and FED-STD 209EISO 14644-1 Class N FED-STD 209E FED-STD 209EMetric1231M1.5410M2.55100M3.561,000M4.5710,000M5.58100,000M6.59> 100,0008.1-Classification of Cleanroom or Controlled environmentThe project determines the level of cleanliness for each Clean Room or Controlled Environment they will use. The project or customer will provide the Contamination Control personnel with the project requirements. The customer operating facilities will determine the classification level they require for the Clean Room or Controlled Environment based on all usage . If the levels differ, the more stringent classification will apply. All Clean Benches must meet an N 5 or cleaner level.8.2-Re-Certification RequirementsRe-certification tests shall be performed on the cleanrooms at specific intervals to demonstrate compliance with ISO 14644-1 according to the classification of the installation. The following is thethe time interval for classes 1 to 9.Class N Re-Certification schedule (Not to exceed # of Days)1 6 months1902 6 months1903 6 months1904 6 months1905 6 months1906 6 months1907 6 months1908 6 months1909 12 months400The customer will be notified 7 days prior to the expiration date of their Certification that aRe-Certification test will be required. The Customer will be notified by phone, Mail or e-mailwhen this is to take place so that a schedule may be set up that will not inconvenience the customer.79.0 CERTIFICATION LABELA Certification label shall be posted in a conspicuous place in or on each certified laminar flow clean room, clean bench or controlled environment. This label will identify the location, (NASA I.D. # on clean benches or clean tents) Classification, Date of Certification, the next Certification date and other tests performed. The test technician will initial and stamp the “certified by” line on the label. (See figure 1)FIGURE 1 (Sample certification label)(NOT TO SCALE)10.0- N ON-COMPLIANCEIn the cases where the cleanroom, controlled environment or clean bench does not meet the specifications of ISO 14644 or the customer does not want the certification, the customer will be notified of the non-compliance condition in writing and by e-mail (return requested) and a label will be posted on the cleanroom, controlled environment or clean bench stating: Notice of Non-compliance- Not Certified. This label (Yellow with red lettering) will have a date and a file number which will be referenced on the memo. (See figure 2) Contamination Control personnel shall maintain a data base record of all Non-compliance clean rooms, controlled environments and clean benches.The non-compliance label shall be posted in a conspicuous place on all non-certified laminar flow clean room, clean bench or controlled environment. This label will identify the location, (NASA I.D. # on clean benches or clean tents) by using a file number and date of the non-compliant condition. Do not remove this label it is to notify the user and Quality Assurance personnel that a non-compliant condition exists and that flight hardware will not be allowed in the clean area or on the clean bench. Contamination Control Services personnel will notify the user of this non-compliant condition by form which will include the date and file number. (See figure 2)FIGURE 2 (Sample of Non-compliance label)(Not to scale)NOTICE OF NON-COMPLIANCENOT CERTIFIEDFOR RECERTIFICATION, CALL (818) 354-4031DATE _______________FILE NO. _________JPL 11007 2/99 FF#11.0-RECORD KEEPINGAfter the certification or non-compliance tests are performed, the test technician will use theprint out data from the particle counter to determine the classification level. The data will be entered into the computer data base and shall include the certification classification or non-Compliance data of the clean room, clean bench or controlled environment, the date of the test, re-certification date, the standard to which the test was performed, the location and identification code or NASA property number.An Inter-Office Memo will be initiated with the classification , differential pressure and velocitydata, customers name, charge number, location of the work performed and the calibration date of the particle counter. One copy of this information will be sent to the customer, and one copy will be retained in the Contamination Control Lab files along with the raw data collected. A copy will also be sent to the Disaster Recovery file in Bldg. 125.9D-1787411.0-Record keeping (Cont.)Certification and non-compliance records are kept in the Contamination Control Lab computerdata base and in hard copy form together with the raw data created during the certification process. The customer may upon request inspect either forms of data control records. These active records are maintained on file for ten years in accordance with JPL Analytical Chemistry Laboratory Technical Instruction 1b.12.0-REPORTING TO THE CUSTOMERThe Contamination Control Laboratory will provide the customer with all the data related to the customers clean room, controlled environment or clean bench for compliance with the ISO standards in a memo form. The Contamination Control Lab personnel will provide a Certification form and place a Certification label on the customers clean room, controlled environment or clean bench when they meet the compliant conditions. In a Non-compliant condition the customer will be notified by mail using a survey form with a file number which matches the file number on the non-compliant label placed in a conspicuous area of the clean room, controlled environment or clean bench. The customer shall also be contacted by telephone and notified of this non-compliant condition.13.0- BASIC RULES FOR JPL AND ASSOCIATED OFF SITE CLEAN ROOMSA copy of the “Rules for the JPL clean rooms” will be provided at the completion of the certification process. These rules shall be sent along with the data included in 12.0 (Reporting to the customer)See Figure 3.14.0-HOW TO OBTAIN CERTIFICATION SERVICESTo request Certification of your Clean Room, Controlled Environment, Clean Zone or Clean Bench, call the Contamination Control Lab at 4-4031 or 4-3465. The Contamination Control Lab works from Services Request forms supplied to the customer or by Work Authorization Memos.10FIGURE 3Contamination Control CapabilitiesClean room Certification to ISO 14644 Standards and JPL Contamination control monitoring plan D-17874Clean room and laminar flow bench maintenance programsClean room tent and curtain installationsClean room HEPA and ULPA filter replacements and repairsPre-filter maintenance programsLaminar flow clean bench certifications, repairs and refurbishment Laminar flow clean bench procurementsTesting of environmentally controlled areasLong term airborne particulate monitoring (Light scattering method) Clean room conversions and upgradingMotorized HEPA and ULPA filter installationsAir Velocity testingDifferential pressure testingClean room consultingClean room materials testing for particulate and outgassingClean room airborne particulate (Microscopic method)Molecular contamination testingFlight hardware Low-Volatile/ Non- volatile Residue testingSampling for large particulates in clean rooms (Microscopic method) Particulate sizing and counting (Microscopic method)Contamination identification and analysisClean room supply procurementsClean room contamination control plansOff site facility consulting and testing (NASA/JPL contracts)Flight hardwareCalorimeter fabrication, assembly and testingVacuum pressure gauge fabrication, assembly and testingMaterials list review and recommendationsParticulate and molecular analysisContamination control monitoringEngineering supportTechnician supportPlease contact: William Neiderheiser at (818) 354-3465orLinda Love at (818) 354-4031 to schedule services。